# FDA recall Z-1906-2021

> **Beckman Coulter Inc.** · Class II · device recall initiated 2021-05-07.

## Product

Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751

## Reason for recall

SARS-CoV-2 lgG II numerical results  may potentially  be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.

## Distribution

US: Alabama,  Alaska,  Arizona,  Arkansas,  California,  Florida,  Georgia,  Illinois,  Iowa,  Kentucky,  Louisiana,  Maine,  Maryland,  Massachusetts,  Michigan,  Mississippi,  Missouri,  New Hampshire,  New Jersey,  New York,  North Dakota,  Ohio,  Oklahoma,  Pennsylvania,  Puerto Rico,  Tennessee,  Texas,  Virginia,  West Virginia,  Wisconsin,  Wyoming,    OUS: Andorra, Austria, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Jordan, Poland, Portugal, San Marino, Slovakia, Slovenia, Spain, United Arab Emirates

## Key facts

- **Recall number:** Z-1906-2021
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-07
- **Report date:** 2021-06-30
- **Termination date:** 2023-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1906-2021

## Citation

> AI Analytics. FDA recall Z-1906-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1906-2021. Source: US FDA. Licensed CC0.

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